Aptima Combo 2
assay

The FDA-cleared and CE-marked kit for the qualitative detection of both Chlamydia trachomatis and Neisseria gonorrhoeae, the Aptima Combo 2 assay utilizes the target capture of rRNA with proven detection of these often asymptomatic pathogens that, when left untreated, can cause permanent reproductive health complications.3 Available on the fully automated Panther® system, the assay provides definitive results on a scalable testing platform to meet the demands of sexually transmitted infection screening programs. Epidemiological trends of Chlamydia trachomatis infection are quite similar to Mycoplasma genitalium.4


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The Aptima
Trichomonas
vaginalis assay

The Aptima Trichomonas vaginalis assay was first to market as an FDA-cleared and CE-marked nucleic acid amplification test (NAAT) for the qualitative detection of Trichomonas vaginalis. CDC guidelines recommend NAAT for detecting Trichomonas vaginalis over less sensitive methods such as wet-mount microscopy.8 Available on the fully automated Panther system, the Aptima Trichomonas vaginalis assay utilizes many of the same sample types as our Aptima Combo 2 assay, including specimens collected in PreservCyt® solution.9 Epidemiological trends of Trichomonas vaginalis  infection indicate a prevalence higher than chlamydia and gonorrhea combined.10


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Aptima HPV assay

The Aptima HPV assay offers a unique screening approach by targeting high-risk human papillomavirus (HPV) mRNA from the E6/E7 oncogenes. The Aptima HPV assay offers the same excellent sensitivity and improved specificity as compared to DNA-based tests. 12-28 Although up to 80% of the population will have an HPV infection at some point in life, very few will go on to develop cervical cancer. 29,30 The Aptima HPV assay targets high-risk HPV mRNA. Studies have shown that mRNA reflects the presence and activity of a high-risk HPV infection. Identifying E6/E7 mRNA is indicative of those HPV infections destined to lead to disease. 31,32

24% reduction in false positives. 24

-24%

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APTIMA HPV 16
18/45 GENOTYPE
ASSAY

The first FDA-approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45 from patient samples testing positive for HPV.33 HPV types differ in the levels of risk that they confer for developing severe dysplasia or cervical carcinoma. Genotyping of HPV in women with negative cytology who are HPV-positive aims to improve risk stratification and to ensure appropriate follow-up of patients. Among the 14 high-risk HPV types, HPV types 16, 18, and 45, are associated with around 80% of all invasive cervical cancers worldwide.34 These 3 HPV types are present in approximately 75% of all squamous cell carcinomas and up to 94% of cervical adenocarcinomas.34

0

type
0

type
0


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Aptima
Mycoplasma
genitalium assay

The CE-marked diagnostic kit for the detection of this often overlooked sexually transmitted infection, the Aptima Mycoplasma genitalium assay is a NAAT testing solution for this fastidious organism.4 Available on the fully automated Panther system, this assay conveniently utilizes the same patient sample types as Aptima Combo 2 testing, in addition to penile meatal swabs. 4 Often asymptomatic like Chlamydia trachomatis and Neisseria gonorrhoeae, studies show Mycoplasma genitalium prevalence to be higher than Neisseria gonorrhoeae and epidemiological trends quite similar to Chlamydia trachomatis. 8,36-37

10-30%
of women with clinical
cervicitis have M. genitalium.38
9%
may have a life-threatening
tubal pregnancy.39
20%
may become infertile.39
37%
Responsible for 37% of
persistent or recurrent
urethritis cases in men.

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Aptima Zika Virus
Assay

Under FDA Emergency Use Authorization and CE-mark, the Aptima Zika Virus assay is a transcription-mediated amplification test intended for the qualitative detection of Zika virus RNA.40 Available on the fully automated Panther system, this assay provides single-digit limit of detection of this mosquito-borne, sexually transmitted pathogen in sample types, including serum, plasma and urine.40 Results for the identification of Zika virus should be managed in consultation with public health or other authorities to whom reporting is required (reporting to the CDC is required in the U.S.)*.

*This test has not been FDA cleared or approved;This test has been authorized by FDA under an EUA for use by authorized laboratories;This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection undersection 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Processed Urine

Plasma or Serum

Single
Digit

c/ml40


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Aptima HSV 1 & 2
Assay

An FDA-cleared and CE-marked NAAT for the qualitative detection of herpes simplex virus types 1 and 2, the Aptima HSV 1 & 2 assay differentiates between types to aid providers in managing patient therapy.41 Both CDC and IUSTI guidelines recommend NAAT for detecting HSV-1 and HSV-2. 8,42 The Aptima HSV 1 & 2 is available on the fully automated Panther system, which is fully scalable to meet test volume needs of any lab.41 Epidemiological trends indicate that more than 3.7 billion people globally are infected with HSV-1 or HSV-2. 43

Preterm birth
Miscarriage
Risk of passing infection to baby

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Aptima specimen collection kits

Refer to the assay package insert for additional information
on approved sample types.

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The Panther System

With true sample-to-result automation, adaptable workflow options and assays using proven TMA technology, the Panther system was built for maximum efficiency.  Efficiency that allows labs to leverage limited resources while increasing lab productivity.

Proven lowest hands-on time minimizes labor requirements.46

Virology and women’s health assays on a single, consolidated platform allow you to leverage limited resources and boost productivity.


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